510(k) K221050

ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System by Aegis Spine, Inc. — Product Code OUR

K221050 is an FDA 510(k) premarket notification submitted by Aegis Spine, Inc. for the device "ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System". The FDA issued a decision of Substantially Equivalent on Jun 30, 2022. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Aegis Spine, Inc. has 5 other 510(k) clearances on record.